Implementation of an Efficacious Intervention for High Risk Women in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,228
- 试验地点
- 8
- 主要终点
- Reduction in number of unprotected sex acts relative to control group
研究概览
简要总结
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Self-identify as female sex worker
- •Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
- •Had unprotected anal or vaginal sex with male client at least once in last 2 months
- •Agree to be tested for HIV & STIs at baseline and 6-month follow-u0
排除标准
- •Previous positive HIV test result
结局指标
主要结局
Reduction in number of unprotected sex acts relative to control group
时间窗: 6 months
Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients. Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Reduction in HIV and STI incidence relative to control group
时间窗: 6 months
Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia. Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
次要结局
- Fidelity to Mujer Segura intervention model(6 months)
研究者
Thomas L. Patterson
Principal Investigator
University of California, San Diego